438.010
Definitions for ORS 438.010 to 438.510. As used in ORS 438.010 to 438.510, unless
the context requires otherwise:

(1)
“Authority” means the Oregon Health Authority.

(2)
“Clinical laboratory” or “laboratory” means a facility where the
microbiological, serological, chemical, hematological, immunohematological,
immunological, toxicological, cytogenetical, exfoliative cytological,
histological, pathological or other examinations are performed on materials
derived from the human body, for the purpose of diagnosis, prevention of
disease or treatment of patients by physicians, dentists and other persons who
are authorized by license to diagnose or treat humans.

(3)
“Clinical laboratory specialty” or “laboratory specialty” means the examination
of materials derived from the human body for the purpose of diagnosis and
treatment of patients or assessment of health, employing one of the following
sciences: Serology, microbiology, chemistry, hematology, immunohematology,
immunology, toxicology, cytogenetics, exfoliative cytology, histology or
pathology.

(4)
“Clinician” means a nurse practitioner licensed and certified by the Oregon
State Board of Nursing, or a physician assistant licensed by the Oregon Medical
Board.

(5)
“Custody chain” means the handling of specimens in a way that supports legal
testimony to prove that the sample integrity and identification of the sample
have not been violated, as well as the documentation describing those
procedures from specimen collection to the final report.

(6)
“Dentist” means a person licensed to practice dentistry by the Oregon Board of
Dentistry.

(7)
“Director of clinical laboratory” or “director” means the person who plans,
organizes, directs and participates in any or all of the technical operations
of a clinical laboratory, including but not limited to reviewing laboratory
procedures and their results, training and supervising laboratory personnel,
and evaluating the technical competency of such personnel.

(8)
“Health screen testing” means tests performed for the purpose of identifying health
risks, providing health information and referring the person being tested to
medical care.

(10)
“High complexity test” means a procedure performed on materials derived from
the human body that meet the criteria for this category of testing in the
specialties of microbiology, chemistry, hematology, immunohematology,
diagnostic immunology, clinical cytogenetics, cytology, histopathology, oral
pathology, pathology, radiobioassay and histocompatibility as established by
the authority.

(11)
“Laboratory evaluation system” means a system of testing clinical laboratory
methods, procedures and proficiency by periodic performance and reporting on
test specimens submitted for examination.

(12)
“Moderate complexity laboratory” means a facility that performs testing
classified as moderately complex in the specialties of microbiology,
hematology, chemistry, immunohematology or diagnostic immunology and may also
perform any waived test.

(13)
“Moderate complexity test” means a procedure performed on materials derived
from the human body that meet the criteria for this category of testing in the
specialties of microbiology, hematology, chemistry, immunohematology or
diagnostic immunology as established by the authority.

(14)
“Operator of a substances of abuse on-site screening facility” or “operator”
means the person who plans, organizes, directs and participates in any or all
of the technical and administrative operations of a substances of abuse on-site
screening facility.

(15)
“Owner of a clinical laboratory” means the person who owns the clinical
laboratory, or a county or municipality operating a clinical laboratory or the
owner of any institution operating a clinical laboratory.

(17)
“Physician performed microscopy procedure” means a test personally performed by
a physician or other clinician during a patient’s visit on a specimen obtained
during the examination of the patient.

(18)
“Physician performed microscopy procedures” means a limited group of tests that
are performed only by a physician or clinician.

(21)
“Substances of abuse on-site screening facility” or “on-site facility” means a
location where on-site tests are performed on specimens for the purpose of
screening for the detection of substances of abuse.

(22)
“Substances of abuse on-site screening test” or “on-site test” means a
substances of abuse test that is easily portable and can meet the requirements
of the federal Food and Drug Administration for commercial distribution or an
alcohol screening test that meets the requirements of the conforming products
list found in the United States Department of Transportation National Highway
Traffic Safety Administration Docket No. 94-004 and meets the standards of the
United States Department of Transportation Alcohol Testing Procedure, 49 C.F.R.
part 40, in effect on October 23, 1999.

438.030
Policy.
It shall be the declarative purpose of ORS 438.010 to 438.510 to ensure the
quality of medical laboratory work in order to protect the health and welfare
of the people of the State of Oregon by establishing a regulatory program for
clinical laboratories. [1969 c.685 §1; 2001 c.104 §169]

(1)
For any owner or director of a clinical laboratory to operate or maintain a
clinical laboratory without a license issued under ORS 438.110 or without a
temporary permit issued under ORS 438.150 or to perform or permit the
performance of any laboratory specialty for which the laboratory is not
licensed except as specified under ORS 438.050, unless the laboratory has been
issued a valid certificate from the federal government under the Clinical
Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and
263a).

(2)
For an out-of-state laboratory to perform health screen testing in Oregon
without a permit issued under ORS 438.150 (5).

(3)
For any person to serve in the capacity of director of a clinical laboratory
without being qualified as a clinical laboratory director under ORS 438.210. [1969
c.685 §3; 1999 c.341 §1; 2005 c.22 §298]

438.050
Application; exceptions. (1) ORS 438.010 to 438.510 apply to all clinical
laboratories and laboratory personnel within the State of Oregon, except:

(a)
Clinical laboratories operated by the United States Government.

(b)
Clinical laboratories operated and maintained purely for research or teaching
purposes, and that involve no patient or public health services.

(2)
Nothing in ORS 438.010 to 438.510 is intended to confer on any licensed
practitioner of the healing arts any authority the practitioner would not
otherwise possess under the license. [1969 c.685 §§4,20; 1973 c.829 §54; 1979
c.193 §1; 1993 c.109 §4; 2001 c.104 §170]

438.055
Exemption.
Clinical laboratories operated by physicians or clinicians that conduct only
waived tests and physician performed microscopy procedures used exclusively for
the diagnosis and treatment of their patients shall not be subject to
regulation that is more strict than regulation imposed under the Clinical
Laboratory Improvement Amendments of 1988 (P.L. 100-578; 42 U.S.C. 201 and
263a). [1993 c.109 §12; 1999 c.341 §2]

438.060
Permit for health screen testing; exception. Notwithstanding ORS 438.050, any
person performing health screen testing must obtain a permit under ORS 438.150
(5). However, an employer providing health screen testing to employees of the
employer is exempt from the applications of ORS 438.010, 438.130, 438.150 and
this section if such employer contracts for the testing through a licensed
physician, a clinical laboratory or a hospital, which is a permittee of the
Oregon Health Authority as provided in this section. [1989 c.776 §3; 2009 c.595
§699]

438.070
Personnel; rules.
The Oregon Health Authority shall establish by rule the qualifications and
responsibilities of technical and clinical consultants, general and technical
supervisors and testing personnel. A person is qualified to act as a technical
or clinical consultant, a general or technical supervisor, or a testing person
in a clinical laboratory if the person meets the requirements established by
the authority. Rules adopted under this section shall not be more stringent
than comparable rules adopted under the Clinical Laboratory Improvement
Amendments of 1988 (P.L. 100-578; 42 U.S.C. 201 and 263a). [1993 c.109 §2; 2009
c.595 §700]

(Clinical
Laboratory License)

438.110
Standards for issuance and renewal of laboratory license. (1) The Oregon
Health Authority shall establish four levels of laboratory licenses as follows:

(a)
A high complexity laboratory license;

(b)
A moderate complexity laboratory license;

(c)
A physician performed microscopy laboratory license; and

(d)
A waived laboratory license.

(2)
The authority shall issue and renew licenses required under ORS 438.040 for any
or all clinical laboratory specialties to the owners of clinical laboratories
who demonstrate to the satisfaction of the authority that:

(a)
The clinical laboratory is in compliance with ORS 438.010 to 438.510 and the
rules of the authority adopted under ORS 438.450;

(b)
The laboratory is adequately equipped to perform proficiently within the scope
of its license;

(c)
The clinical laboratory has facilities for retaining and does retain complete
laboratory records for an appropriate length of time as the authority by rule
may require; and

438.120
Standards for licensing specialties; exceptions. (1) In determining
the specialties that are authorized to be performed in a clinical laboratory,
the Oregon Health Authority shall consider laboratory personnel, with
particular emphasis on the qualifications of the director, laboratory equipment
and any other relevant factors affecting the ability of the laboratory to
perform different laboratory specialties.

(2)
No laboratory shall be licensed to perform examinations in the fields of
surgical pathology, autopsy pathology, exfoliative cytology, or
immunohematology, unless its director is a physician or dentist specifically
qualified in these fields. The authority may establish exemptions from the
requirements of this subsection for the field of immunohematology.

438.130
License application; fees; expiration and renewal. (1) The
application for a license for a clinical laboratory shall be made on forms
provided by the Oregon Health Authority and shall be executed by the owner or
one of the owners or by an officer of the firm or corporation owning the
clinical laboratory, or in the case of a county or municipality, by the public
official responsible for operation of the laboratory, or in the case of an
institution, by the administrator of the institution. The application shall
contain the names of the owner, the director or directors of the clinical
laboratory, the location and physical description of the clinical laboratory,
the laboratory specialties for which a license is requested and such other
information as the authority may require.

(2)(a)
The application shall be accompanied by an annual or biennial license fee to be
established by the authority. The fee shall be based on test volume, test
complexity, the number of specialties performed and private laboratory
accreditation. For each level of laboratory testing, the fee shall be not more
than 100 percent of the corresponding fee charged by the federal laboratory
certification program known as the Clinical Laboratory Improvement Amendments
of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a) in effect on July 1, 1999. The fee
for substance of abuse screening laboratories not certified under the Clinical
Laboratory Improvement Amendments of 1988 shall be comparable to the clinical
laboratory fee established under this section.

(b)
The authority may establish prorated fees for licenses issued for a year or
less and when there is a change in the laboratory’s owner, director or address.
A prorated license fee shall be issued to a laboratory accredited by an
organization recognized by the authority.

(3)
Unless sooner voided, suspended or revoked, all licenses issued under this
section expire on June 30 of the one-year or two-year cycle following the date
of issuance or on such date as may be specified by authority rule. Licenses
issued under this section shall be renewable in the manner prescribed by the
authority.

(4)
Subject to prior approval of the Oregon Department of Administrative Services
and a report to the Emergency Board prior to adopting the fees and charges, the
fees and charges established under this section shall not exceed the cost of
administering the regulatory program of the authority pertaining to the purpose
for which the fee or charge is established, as authorized by the Legislative
Assembly within the authority’s budget, as the budget may be modified by the Emergency
Board. [1969 c.685 §7; 1977 c.284 §3; 1979 c.696 §2; 1989 c.776 §5; 1991 c.703 §6;
1993 c.109 §7; 1999 c.341 §§5,6; 2007 c.768 §4; 2009 c.595 §703]

438.140
License content; display; nontransferability; voidability; special permit when
director changes.
(1) A license issued to the owner of a clinical laboratory shall show on its
face the names of the owners and directors, the location of the laboratory and
the clinical laboratory specialties authorized under the license. The license
shall be displayed at all times in a prominent place in the laboratory.

(2)
A license issued to the owner of a clinical laboratory is not transferable. The
license of the laboratory is voided 30 days after a change in its director if
it has only one director or if all directors change or a change in the
ownership or in the location of the laboratory. In case of death of a director,
immediate notification to the Director of the Oregon Health Authority or a
designee who shall be empowered to issue a special temporary permit of 30 days’
duration issued to a designated substitute director is required. If a license
is voided or a special temporary permit is issued under this section, a new
license application, accompanied by the nonrefundable license fee prescribed in
ORS 438.130, shall be filed with the authority. [1969 c.685 §8; 2009 c.595 §704]

438.150
Temporary permit; fees; health screen testing permit; conditions and
limitations; rules.
(1) In addition to the license of a clinical laboratory required by ORS
438.040, the Oregon Health Authority may issue a temporary permit valid for a
period, to be determined by the authority, from the date of issuance in any or
all clinical laboratory specialties upon payment of the respective required
fees as described in ORS 438.130 (2).

(2)
In issuing the temporary permit, the authority may require that:

(a)
Plans for compliance with applicable laws and rules be submitted with the
application for the temporary permit;

(b)
During the period in which the temporary permit is in effect periodic reports
be submitted on the progress of the plans for compliance; and

(c)
Special temporary provisions specified by the authority upon application of the
temporary permit be maintained for the protection of the public.

(3)
If at any time the authority determines that the clinical laboratory can no
longer operate in a manner that protects the public health and safety or that
the requirements imposed under subsection (2) of this section are not being
maintained, the authority shall cancel the temporary permit.

(4)
One renewal of the temporary permit may be granted if deemed to be in the best
interest of public health by the authority. The fee for renewal is the
respective required fee as described in ORS 438.130 (2).

(5)
The authority may issue permits for health screen testing.

(6)
The authority by rule shall specify:

(a)
Appropriate quality assurance procedures;

(b)
Personnel qualifications;

(c)
Standards for counseling and referral of persons being tested;

(d)
Tests a health testing service may conduct;

(e)
The procedure for applying for a permit; and

(f)
The procedure for reporting to the authority the location of all health
screening facilities.

(7)
The authority by rule may specify the maximum length of time a health screen
testing service may remain in one location. [1969 c.685 §9; 1989 c.776 §2; 2007
c.71 §122; 2009 c.595 §705]

438.160
Refusal to issue or renew license; suspension or revocation of license or
permit.
Subject to ORS chapter 183, the Oregon Health Authority may refuse to issue or
renew the license, or may suspend or revoke the license or health screen
testing permit, of a clinical laboratory if it finds that the owner or director
has:

(1)
Intentionally made false statements on an application for a clinical laboratory
license or any other documents required by the authority, or made any
misrepresentation in seeking to obtain or retain a license.

(2)
Demonstrated incompetence as defined pursuant to regulations promulgated after
public hearing.

(3)
Intentionally falsified any report.

(4)
Referred a specimen for examination to a nonlicensed or an unlicensed clinical
laboratory in this state unless the laboratory is exempt from the application
of ORS 438.010 to 438.510.

(5)
Misrepresented the scope of laboratory service offered by the clinical
laboratory or the clinical laboratory specialties authorized by the license.

(6)
Rendered a report on clinical laboratory work actually performed in another
clinical laboratory without designating the name and address of the clinical
laboratory in which the test was performed.

(7)
Knowingly had professional connection with or permitted the use of the name of
the licensed clinical laboratory or its director by a clinical laboratory that
is required to but has not obtained a license.

(8)
Failed to perform or cause to be performed within the time specified analysis
of test samples as authorized by ORS 438.320, or failed to report on the
results of such analysis within the specified time.

(9)
Failed to permit within a reasonable time the entry or inspection authorized by
ORS 438.310.

(10)
Failed to continue to meet requirements of ORS 438.110 and 438.120.

438.210
Qualifications of laboratory director. A person is qualified to act as a
laboratory director of a clinical laboratory if:

(1)
The person is a pathologist certified in clinical or anatomical pathology by a
national organization or organizations recognized by the Oregon Health
Authority, or is a physician who possesses qualifications equivalent to those
required for such certification;

(2)
The person is a physician who possesses special qualifications that enable the
person to perform as a laboratory director, or is directing a laboratory on
January 1, 1970;

(3)
The person has an earned degree of Doctor of Science or Doctor of Philosophy,
or an acceptable degree as determined by the authority, from an accredited
college or university, with a major in the chemical, physical, or biological
sciences and possesses special qualifications as described in the
administrative rules of the authority that enable the person to perform as a
laboratory director;

(4)
The person is a member of a group of five or more physicians who operate on
November 4, 1993, a laboratory performing work only on their patients and is
the member designated by the group to be the director; or

(5)
The person was responsible for the direction of a clinical laboratory for at
least 12 months within the five years preceding January 1, 1970, and has had at
least two years of pertinent clinical laboratory experience, as determined by
the authority. [1969 c.685 §12; 1993 c.109 §8; 2007 c.71 §123; 2009 c.595 §707]

438.220
Special qualifications for laboratory director at chiropractic college. Notwithstanding
ORS 438.210, a person is qualified to act as the laboratory director of the
clinical laboratory at any accredited chiropractic college in this state for
the benefit of chiropractic patients if that person is a chiropractic physician
licensed by the State Board of Chiropractic Examiners, and possesses special
qualifications, as determined by the State Board of Chiropractic Examiners,
that enable that person to perform as a laboratory director. [1979 c.303 §2]

(a)
At reasonable times enter the premises of a clinical laboratory licensed or
subject to being licensed under ORS 438.010 to 438.510 to inspect the
facilities, methods, procedures, materials, staff, equipment, laboratory
results and records of the clinical laboratory.

(b)
Require the owner or director to submit reports on the operations and
procedures of the laboratory.

(c)
Require the owner or director to submit initial laboratory findings indicative
of communicable disease as defined by law or by rule. Each report shall include
the name of the person from whom the specimen was obtained, if the name was
reported to the laboratory, and the name and address of the physician for whom
such examination or test was made. Such reports shall not be construed as
constituting a diagnosis nor shall any laboratory making such report be held
liable under the laws of this state for having violated a trust or confidential
relationship.

(2)
The Director of the Oregon Health Authority or a designee, the authority, or
any employee thereof, shall not disclose information contained in reports on
communicable diseases submitted to the authority under subsection (1) of this
section except as such information is made available to employees of the
authority and to local health officers for purposes of administering the public
health laws of this state. However, information contained in such reports may
be used in compiling statistical and other data in which persons are not
identified by name or otherwise.

(3)
The authority shall by rule set standards for the recognition of private
laboratory accrediting organizations whose standards meet or exceed federal
standards. A laboratory that is accredited by a private laboratory accrediting
organization recognized by the authority under this section may submit proof of
such accreditation to the authority. Upon receipt of such proof, the authority
shall issue a license pursuant to ORS 438.130. [1969 c.685 §13; 1993 c.109 §9;
2001 c.104 §173; 2009 c.595 §708]

438.320
Laboratory evaluation system; rules; quality control systems. (1) The Oregon
Health Authority shall institute a laboratory evaluation system, as defined in
ORS 438.010, and shall make such rules as are necessary to insure quality
control of laboratory work.

(2)
As part of this system, the authority may require each laboratory to:

(a)
Participate in on-site inspection and testing;

(b)
Analyze test samples submitted by the authority prior to, during or subsequent
to the inspection; and

(c)
Contract with, at the laboratory’s own expense, an authority-approved source of
test samples for such test samples to be submitted periodically to the
laboratory and to be returned to that source for grading after testing. The
test results shall be made available to the authority.

(3)
The procedures under subsection (2) of this section shall be referred to as
external quality control. The samples are to be tested by regularly assigned
personnel using routine methods. The test samples shall be confined to the
specialty of the laboratory as indicated on the license. A specified time shall
be allowed for such testing and reporting of the results and shall be the time
required under conditions of normal operation.

(4)
In addition to external quality control, each clinical laboratory shall
establish an internal laboratory quality control system pursuant to rules of
the authority including but not necessarily limited to the testing of reference
or control sera and other biological samples, verifying concurrent calibration
standards and control charts recordings, and reporting on its control system as
required by the authority. [1969 c.685 §14; 1983 c.740 §154; 1993 c.109 §10;
2009 c.595 §709]

438.410 [Formerly
433.310; repealed by 1971 c.650 §51]

(Miscellaneous)

438.420
Communicable disease reports to be from licensed laboratory. When the control
or release of a case contact or carrier of a communicable disease is dependent
on laboratory findings, the health officer may require such findings to be
obtained by a clinical laboratory licensed by the Oregon Health Authority. [Formerly
433.325; 2009 c.595 §710]

438.430
Examination, specimens; reports and results. (1) Except as otherwise provided
in ORS 438.010 to 438.510, a clinical laboratory shall examine specimens only
at the request of a physician, dentist, or other person authorized by law to use
the findings of laboratory examinations.

(2)
A person may not report the result of any test, examination, or analysis of a
specimen submitted for evidence of human disease except to:

(a)
The patient; and

(b)
A physician, dentist, their agents, or other person authorized by law to employ
the results thereof in the conduct of a practice or in the fulfillment of
official duties.

(3)
A clinical laboratory shall provide the results of a test, examination or
analysis of a specimen submitted by a patient in writing to the patient:

(a)
Not sooner than seven days after receiving a request for the results from the
patient; or

(b)
Immediately upon receiving authorization from the doctor, dentist or other
person who requested the test, examination or analysis to provide the results
to the patient. [1969 c.685 §21; 2001 c.104 §174; 2003 c.376 §1; 2009 c.583 §1]

438.435
Testing for substance of abuse; rules; fees. (1) In addition to duties which a
clinical laboratory may perform under ORS 438.010 to 438.510, a laboratory is
authorized to perform appropriate tests, examinations or analyses on materials
derived from the human body for the purpose of detecting substances of abuse in
the body. All laboratories performing the tests, examinations or analyses must be
licensed under the provisions of ORS 438.010 to 438.510 and must employ
qualified technical personnel to perform the tests, examinations and analyses.

(2)
In order to perform such tests, examinations or analyses, the laboratory may
examine specimens submitted by persons other than those described in ORS
438.430 (1) and shall report the result of any test, examination or analysis to
the person who submitted the specimen. When the substance of abuse test is for
nonmedical employment or pre-employment purposes, and a written request is
provided, the test result shall be reported to the person from whom the
specimen was originally obtained.

(3)
When the specimen of a person tested for substances of abuse is submitted to
the laboratory and the test result is positive, the laboratory shall perform a
confirming test which has been designated by rule of the Oregon Health
Authority as the best available technology for use to determine whether or not
the substance of abuse identified by the first test is present in the specimen
prior to reporting the test results.

(4)
The authority by rule shall set standards for special category laboratories
that engage only in the initial testing for substances of abuse in the body,
including registration procedures for such laboratories and personnel.

(5)
The operator of a substances of abuse on-site screening facility may use
substances of abuse on-site screening tests if the test results are not for use
in diagnosing or preventing disease and are not for use by physicians, dentists
or other licensed health care professionals in treating humans. Any entity
using the test shall pay a yearly filing fee, not to exceed $50, and file a
registration form as provided by rule of the authority that:

(a)
States the current name and address of the entity, the telephone number of the
entity, if any, and the name of a contact individual at each on-site facility
operated by the entity; and

(b)
Certifies that:

(A)
The tests are being administered according to the federal Food and Drug Administration
package insert that accompanies the test;

(B)
The tests are being administered according to the instructions of the
manufacturer;

(C)
Custody chain procedures are being followed;

(D)
Operators of the substances of abuse on-site screening facility are trained in
the use of the substances of abuse on-site screening tests by the manufacturer;
and

(E)
If the substances of abuse on-site screening facility obtains a positive test
result on a specimen and the entity indicates that the test result is to be
used to deny or deprive any person of employment or any benefit, or may
otherwise result in adverse employment action, the same specimen shall be
submitted to a clinical laboratory licensed under ORS 438.110 and 438.150 or an
equivalent out-of-state facility and the presence of a substance of abuse
confirmed prior to release of the on-site test result.

(6)
The authority by rule shall set reasonable standards for the screening by
correctional agencies of inmates within state and local correctional facilities
and offenders on parole, probation or post-prison supervision for substances of
abuse. The standards shall include, but not be limited to, the establishment of
written procedures and protocols, the qualifications and training of
individuals who perform screening tests, the approval of specific technologies
and the minimum requirements for record keeping, quality control and
confirmation of positive screening results.

(7)
If an initial test by a special category laboratory under subsection (4) of
this section or a special category screening under subsection (6) of this
section shows a result indicating the presence of a substance of abuse in the
body, a confirmatory test shall be conducted in a licensed clinical laboratory
if the results are to be used to deprive or deny any person of any employment
or benefit. If a screening test of an inmate of a state or local correctional
facility is positive for a substance of abuse, the inmate may be held in a
secure facility pending the outcome of the confirmatory test. If the
confirmatory test is positive, the inmate may be held in a secure facility
pending the outcome of any hearing to determine what action will be taken.

(8)
If any test for substances of abuse is performed outside this state the results
of which are to be used to deprive or deny any person any employment or any
benefit, the person desiring to use the test shall have the burden to show that
the testing procedure used meets or exceeds the testing standards of this
state. [1987 c.669 §2; 1991 c.808 §1; 1997 c.355 §2; 1999 c.739 §2; 2001 c.104 §175;
2009 c.595 §711]

438.440
Disposition of fees.
All moneys received by the Oregon Health Authority under ORS 438.010 to 438.510
and 438.990 shall be credited to the Public Health Account and shall be used
for payment of the expenses of the authority in administering the provisions of
ORS 438.010 to 438.510 and 438.990. [1969 c.685 §16; 2009 c.595 §712]

438.450
Rules.
The Oregon Health Authority shall make such rules as are necessary for carrying
out ORS 438.010 to 438.510 in accordance with ORS 183.330. [Formerly 433.335;
2001 c.104 §176; 2009 c.595 §713]

438.510
Prohibited acts.
It is unlawful for the owner of a clinical laboratory or the director of a
clinical laboratory to:

(1)
Operate or maintain a clinical laboratory unless the laboratory is under
personal supervision of a director who is qualified to supervise the
laboratory.

438.605
Definitions for ORS 438.605 to 438.620, 448.280 and 448.285. As used in ORS
438.605 to 438.620, 448.280 and 448.285:

(1)
“Accrediting authority” means the official accrediting authority for the Oregon
environmental laboratory accreditation program comprised of the Director of the
Oregon Health Authority or designee, the Director of the Department of
Environmental Quality or designee and the Director of Agriculture or designee.

(a)
Rules adopted or enforced by the Oregon Health Authority, the Department of
Environmental Quality or the State Department of Agriculture; or

(b)
A federal environmental statute or regulation administered or enforced by the
United States Environmental Protection Agency. [1999 c.1063 §1; 2009 c.595 §714]

438.610
Standards for accreditation; rules. (1) The Oregon Health Authority, in concurrence
with the accrediting authority, may adopt by rule standards for any laboratory
seeking accreditation and performing environmental testing for a fee or for
determining compliance with environmental statutes, rules or regulations.

(2)
In developing standards under subsection (1) of this section, the authority
shall cooperate with and may seek advice from the United States Environmental
Protection Agency and any other state or federal agency that may have adopted
rules or regulations for environmental monitoring.

(3)
The standards adopted under this section may address testing and sampling
procedures or methods, record keeping, disposal or retention of testing
materials or samples, or any other practice related to work performed by an
environmental laboratory. [1999 c.1063 §2; 2009 c.595 §715]

438.615
Environmental laboratory accreditation program; rules. The Oregon Health
Authority, in concurrence with the accrediting authority, shall establish by
rule and implement an environmental laboratory accreditation program. The
standards for accreditation may be equivalent to, but may not exceed, standards
adopted by national accreditation programs. [1999 c.1063 §3; 2009 c.595 §716]

438.620
Accreditation fees; disposition of fees. (1) In conjunction with the environmental
laboratory accreditation program established under ORS 438.615, the Oregon
Health Authority may establish and collect a fee for laboratory accreditation
under the program. A fee imposed under this section shall not exceed the cost
of administering the program.

(2)
Prior to imposing the fee under subsection (1) of this section, the authority
shall obtain the approval of the Oregon Department of Administrative Services
and report to the appropriate legislative committee.

(3)
All moneys collected by the Oregon Health Authority under this section shall be
deposited in a dedicated account of the authority. Such moneys are continuously
appropriated to the Oregon Health Authority to pay the costs of the authority,
the State Department of Agriculture and the Department of Environmental Quality
in administering the environmental laboratory accreditation program established
under ORS 438.615. [1999 c.1063 §4; 2009 c.595 §717]

ANATOMICAL
MATERIAL

438.705
Definitions for ORS 438.705 to 438.720 and 438.994. As used in ORS
438.705 to 438.720 and 438.994:

(1)
“Anatomical material” means the body of a dead human or a cell, group of cells
or body part taken from the body of a dead human.

(2)
“Donor” has the meaning given that term in ORS 97.953.

(3)(a)
“Nontransplant anatomical research recovery organization” means a person that
engages in the recovery or distribution of anatomical material from a donor for
research or education purposes other than transplanting the anatomical material
or therapy.

(b)
“Nontransplant anatomical research recovery organization” does not include:

(A)
A hospital or other health care facility, as those terms are defined in ORS
442.015;

(B)
A public corporation, as defined in ORS 353.010;

(C)
A public or private institution of higher education; or

(D)
A clinical laboratory, as defined in ORS 438.010, that is:

(i)
Licensed under ORS 438.010 to 438.510; and

(ii)
Owned or controlled by, or under common ownership with, a hospital described in
subparagraph (A) of this paragraph. [2013 c.356 §1]

438.710
Licensure of nontransplant anatomical research recovery organizations; rules;
fees.
(1) A person may not act as a nontransplant anatomical research recovery
organization unless the person is licensed as a nontransplant anatomical
research recovery organization by the Oregon Health Authority.

(2)
The authority shall adopt rules establishing an application process and fees
for obtaining and renewing a nontransplant anatomical research recovery
organization license. The fee for obtaining or renewing a license under this
subsection may not exceed $1,750.

(3)
A license issued or renewed under this section expires two years after the date
of issuance or renewal.

(4)
The license required by this section is in addition to and not in lieu of any
other license required by law.

(5)
The authority shall deposit fees collected under this section into the Oregon
Health Authority Fund established in ORS 413.101. Moneys deposited in the fund
under this subsection are continuously appropriated to the authority for the
purposes of carrying out the duties, functions and powers of the authority
under ORS 438.705 to 438.720 and 438.994. [2013 c.356 §2]

438.715
Organization operations. (1) A nontransplant anatomical research recovery
organization shall maintain a record of each donor from whom the organization
obtains anatomical material. The record must include:

(a)
Documentation showing that the donor donated the anatomical material for the
purpose of research or education;

(b)
The name and address of each person that had possession of the anatomical
material before the organization took possession of the anatomical material;
and

(c)
Documentation of the disposition of the anatomical material by the
organization, including the name and address of each person that receives
anatomical material from the organization.

(2)
If a nontransplant anatomical research recovery organization returns any
anatomical material to a relative or personal representative of a donor, the
organization shall disclose to the relative or personal representative whether
all or part of the donor’s body is being returned.

(3)
A nontransplant anatomical research recovery organization shall dispose of any
anatomical material not returned to a relative or personal representative of
the donor in accordance with all laws pertaining to the disposition of human
remains.

(4)
If a nontransplant anatomical research recovery organization accepts an offer
from an individual to donate anatomical material to the organization, the
organization shall provide to the individual clear notice as to whether or not
the organization guarantees the coverage of a cost related to transporting and
disposing of the individual’s anatomical material, including coverage of costs
in instances in which the individual or a relative or personal representative
of the individual subsequently rescinds, or the organization later rejects, the
offer of anatomical material. [2013 c.356 §3]

(b)
Inspect the premises and records of a nontransplant anatomical research
recovery organization as is reasonably necessary to determine compliance with
ORS 438.710 and 438.715; and

(c)
In lieu of conducting inspections authorized under paragraph (b) of this
subsection, accept accreditation from an accrediting body approved by the
authority.

(2)
To be approved under subsection (1)(c) of this section, an accrediting body
must:

(a)
Require a nontransplant anatomical research recovery organization to document
processes related to the recovery, handling and distribution of anatomical
material and submit to the accrediting body that documentation.

(b)
Require a nontransplant anatomical research recovery organization to keep and
maintain all records related to the recovery or distribution of anatomical
material for at least 10 years.

(C)
Any inspection of a facility owned or operated by the nontransplant anatomical
research recovery organization. [2013 c.356 §4]

PENALTIES

438.990
Penalties for ORS 438.040 and 438.510. Violation of any provision of ORS 438.040
or 438.510 is a Class A misdemeanor. Each day of continuing violation shall be
considered a separate offense. [1969 c.685 §22; 1977 c.582 §45]

(a)
Impose a civil penalty in an amount not to exceed $1,000 for each violation of
ORS 438.710 or 438.715; and

(b)
Suspend or revoke a license issued or renewed under ORS 438.710 for a violation
of ORS 438.715.

(2)
The authority shall deposit penalties collected under this section into the
Oregon Health Authority Fund established in ORS 413.101. Moneys deposited in
the fund under this subsection are continuously appropriated to the authority
for the purposes of carrying out the duties, functions and powers of the
authority under ORS 438.705 to 438.720 and 438.994. [2013 c.356 §5]